Devices

Medtronic PMA OK’d for DiamondTemp Ablation

FDA has approved a Medtronic PMA for the DiamondTemp Ablation (DTA) system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy. The device is a temperature-controlled open-irrigated radiofrequency (RF) ablation system designed to deliver RF energy during ablations, Medtronic says, adding that it delivers real-time feedback on physical parameters, which can guide physicians as the lesion is being produced. It is embedded with industrial-grade diamonds, which have 200-400 times greater thermal conductivity when compared to materials used in conventional RF ablation catheters. “This thermal conductivity enables a low irrigation flow-rate, and accurate real-time measurements of tissue temperature, resulting in more efficient energy delivery,” it says.

Approval was based on data from the DIAMOND-AF trial. Results demonstrated a freedom from patient complication rate of 96.7% in the DTA group versus 93.4% in the control group. And primary effectiveness for the treatment of AF was met in 79.1% of DTA patients compared with 75.7% of control subjects.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome